b93bb9e2-b373-4f34-946e-f2df052d1562UpdatePublished22024-08-272023-06-14In Commercial DistributionB06224200055PrimaryHIBCCBlack Diamond POCT2420-00552420-0055933442068Osseus Fusion Systems, LLC13.5x55mm Rod, Curved, Black Diamond POCT falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK22210700065116Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.trueActiveNKGPosterior Cervical Screw SystemfalsetrueMoist Heat or Steam Sterilization